Your mission will be to assist in all processes related to Regulatory Affairs, execution of procedures according to the requirements demanded by the international health authorities, with the aim of enforcing compliance with the current health regulations related to the products marketed by Accexible.
The specialist will be responsible for ensuring that our products comply with all the necessary requirements to be used in clinical trials and with all medical device regulations. S/he will collaborate internally with our team to optimize our procedures and keep certificates up to date.
- Collaborate, from a regulatory standpoint, on the development, manufacturing and marketing strategy for the company’s medical devices nationally and internationally.
- Perform file maintenance of product records and tracking of expiration dates and/or current versions.
- Update the technical aspects of legislation related to the products, and inform the collaborators involved.
- Maintain and develop communication with Regulatory Authorities regarding registrations.
- Create and review relevant regulatory documentation for CE certification.
- Maintain appropriate communication with Notified Bodies and Competent Authorities.
- Support the maintenance of the QMS, associated certificates according to ISO 13485 and registrations related to the medical device standard (CE Marking).
- Participate in internal and Notified Body audits.
- Participate in the development of technical documentation, with support from specialized staff.
- In-house staff training on quality and regulatory issues.
- Carrying out the communications required by the Spanish Health Authority.
- Follow-up of updates of applicable legislation and regulations.
- Keeping documentation updated and mitigating identified deviations.
- Maintaining compliance with the agreements we signed with our customers (on specific requirements not implemented in our systems at quality and regulatory level).
- Preparation and management of product dossiers to obtain Health Registrations in third countries.
- Management and follow-up of international registrations.
- Keeping updated the documentation file delivered to each country.
- Training in Biomedical Engineering or similar (Pharmacy, Biology, Biomedical Engineering, etc.).
- Training in Health Registration, PS Legislation and Quality Management is desirable.
- At least 1 year of experience in Regulatory Affairs department of Medical Devices with experience in preparation and review of technical documentation.
- Fluent English (equivalent to Advanced).
- Knowledge of cloud security recommended.
- Attention to detail and good written communication skills.
- Positive attitude towards change and contribution of new ideas.
What it offers:
- Competitive salary.
- Flexible schedule.
- Dynamic work environment.
- Immediate incorporation and permanent contra
If you are interested please send your CV to email@example.com
AcceXible aims at the early detection and monitoring of diseases through speech analysis by identifying vocal bio-markers using artificial intelligence techniques. We are located in Bilbao and Barcelona.